FDA 510(k)

PENTAX 医疗 EPK-i7010 和 PENTAX EPK-i5010 视频处理器带 GI 系列内镜

K号: K191282 · 2019-11-08

决定日期2019-11-08

产品代码PEA

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决定实质等同

器械摘要

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191282. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Pentax of America, Inc.. The 510(k) number is K191282.

When did PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family receive FDA 510(k) clearance?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191282.

Who is the listed applicant for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

The FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is PEA.

列明Pentax of America, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251256PENTAX 医疗视频上消化道镜 (EG 系列) (EG 系列)；PENTAX 医疗视频结肠镜 (EC 系列) (EC 系列)K251127PENTAX 医疗视频处理器 (EPK-i8020c)K242110PENTAX 医疗视频结肠镜 (EC38-i20cWL)K241213PENTAX 医疗视频上消化道镜 (EG27-i20c)；PENTAX 医疗视频结肠镜 (EC34-i20cL)K233942PENTAX 医疗视频十二指肠镜 (ED34-i10T2s)；PENTAX 医疗视频处理器 (EPK-i8020c)；PENTAX 医疗一次性，无菌远端帽带提升器 (OE-A63)；气/水供应阀门 (OF-B194 )K240457C2 冷冻球囊消融系统（C2 冷冻球囊消融系统）

查看所有 39 个设备 →

相关器械（代码：PEA）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251127PENTAX 医疗视频处理器 (EPK-i8020c)Pentax of America, Inc.K231249PENTAX 医疗视频处理器 EPK-i8020c，PENTAX 医疗视频上消化道镜 EG29-i20c，PENTAX 医疗视频结肠镜 EC38-i20cLPentax of America, Inc.K190805PENTAX 医疗视频处理器 EPK-i5500c，PENTAX 医疗视频上消化道镜 EG29-i10c，PENTAX 医疗视频结肠镜 EC34-i10cL，PENTAX 医疗视频结肠镜 EC38-i10cLPentax of America, Inc.K173679PENTAX 医疗 EPK-i7010 视频处理器带 EB 系列内镜Pentax of America, Inc.K160275带有FuseBox处理器的Fuse内窥镜系统Endochoice, Inc.

官方来源

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